A Study to Assess the Effect of Intravenous Dose of (aMBMC) to Subjects With Non-ischemic Heart Failure

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A Phase IIa Randomized Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Non-ischemic Heart Failure

Safety will be evaluated by the incidence, severity, and relationship of AEs and SAEs [ Time Frame: Change from Baseline, days 30, 60, 90, days 270 and 450 post initial infusion ]

Secondary Outcome Measures
:

Change in LVEF from baseline to day 90 post-initial infusion. After crossover phase all subjects will be evaluated for changes from the new baseline (Day 90 after initial infusion) to Day 90 post second infusion. [ Time Frame: Baseline to Day 90 ]

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Males and females ≥18 years of age

LVEF ≤35% on echocardiogram within 12 months of randomization to undergo MRI

Screening cardiac MRI at baseline with:

Ejection fraction ≤40% No significant hyper enhancement on MRI scan in the opinion of the central imaging lab reviewer

Presence of any other clinically-significant medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the investigator or sponsor for which participation in the study would pose a safety risk to the subject

Inability to comply with the conditions of the protocol

Malignancy within the previous five years, except adequately treated basal cell carcinoma, provided that it is neither infiltrating nor sclerosing, and carcinoma in situ of the cervix

Active myocarditis or early postpartum cardiomyopathy (within six months).

Clinically relevant abnormal findings in the clinical history, physical examination, ECG, or laboratory tests at the screening assessment that would interfere with the objectives of the study or would preclude safe completion of the study. Abnormal findings could include: known HIV infection or other immunodeficiency state, chronic active viral infection (such as hepatitis B or C), acute systemic infections (defined as patients undergoing treatment with antibiotics), gastrointestinal tract bleeding, or any severe or acute concomitant illness or injury

Any other medical, social, or geographical factor that would make it unlikely that the patient could comply with study procedures (e.g., alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or noncompliance)